FDA label a8c7545c-1553-beac-e053-2995a90a3de3

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
a212e12c-2bef-f3dd-e053-2995a90adcd8
SPL ID
a8c7545c-1553-beac-e053-2995a90a3de3
Version
3
Effective date
2021-01-27
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:52:15

Boxed warning cross-check#

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Boxed warning sections page 1 of 1 · 2 matching rows.

boxed warning

236 Drug Facts Box Benzalkonium Chloride 0.1% Antiseptic Uses For handwashing to decrease bacteria on the skin Recommended for repeated use For external use only When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children In case of accidental ingestion, seek medical attention or contact a poison control center immediately. Directions Wet hands and forearms Apply enough product to adequately cover the entire surfaces of the hands and forearms Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles) Rinse thoroughly with water. Other Information Store in a cool dry place below 104°F Inactive Ingredients Water, Amines, C10-C16-alkyldimethyl, N,oxides, PEG-10 Sorbitan Laurate, C9-11 Pareth-6, Undeceth-5, Triethanolamine, Hydroxypropyl Methylcellulose, Sodium Chloride, DMDM Hydantoin.

boxed warning

234 Drug Facts Box Benzalkonium Chloride 0.1% Antiseptic Uses For hand sanitizing to decrease bacteria on the skin Recommended for repeated use For external use only. Do not use in eyes. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together briskly until dry. Inactive Ingredients Water, Cocamidopropyl PG-dimonium chloride phosphate, Dihydroxyethyl cocamine oxide, Acetamidoethoxyethanol, Citric acid.

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

For external use only When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

warnings

For external use only. Do not use in eyes. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.